The development and commercialization of many processes in the fields of medicine, chemistry, and agriculture require the use of bioprocessing containers. Cells have typically been grown in vitro in glass, metal, or hard plastic vessels. However, because these culture vessels are not disposable, they are expensive and require maintenance. Particularly, to maintain a sterile or aseptic environment for cell culture, the vessels require sterilization, usually by autoclave or aseptic disinfection. Thus, they must be washed and sterilized prior to and/or subsequent to use. In addition, because glass, metal, and hard plastic vessels are not disposable, it is necessary to have a large amount of space to accommodate storage.
In addition, the expense of producing cells, biopharmaceuticals, biologicals, and the like is often exacerbated by the required cleaning, sterilization, and validation of conventional bioprocessing containers (i.e., metal, glass, or hard plastic vessels). Attempts have been made to solve this problem with the development of pre-sterilized disposable bioprocessing containers constructed from sheets of flexible, gas-impermeable film that conventionally include at least one ethylene vinyl alcohol (EVOH) layer to increase the gas barrier properties of the structure. As is well known, the barrier properties of EVOH are suitable in low humidity conditions, but degrade substantially when exposed to high humidity. In addition, films typically used for flexible cell culture bags include film surface modifying additives (such as antifogging agents, antistatic agents, anti-blocking agents, and the like) that inhibit cell culture growth.
Therefore, it would be beneficial to provide a flexible film suitable for bioprocessing applications that maintains barrier properties at low, intermediate, and high humidity conditions. It would also be advantageous if the disclosed flexible film was free of surface-modifying additives such that the growth of biological cell cultures is supported.